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OpenTrials
Completed

NCT Number: NCT01335906

Evidence-informed Choice for Women Participating in Mammography Screening

Study objectives: to evaluate the effects of information about benefits and risks of mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision. Study hypothesis: information about benefit and risks of mammography screening increases the women´s knowledge of it; allows women to make an informed decision on whether to stop or continue the screening program, changing the actual participation rate; anxiety and fear are not increased. Design: randomized controlled clinical trial with non-pharmacological intervention. Subjects and setting of study: women referred to mammography screening in the District Bay of Cádiz-La Janda. Interventions: random assignment of women in two arms according to the information provided. Control arm is the standard information; it consists of receiving information normally provided to women attending the screening program for breast cancer. Intervention arm is the experimental information and consists of receiving accurate verbal and written information about the benefits and real risks of mammography screening programs by a physician investigator. Determinations: knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision.

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Key information

Conditions

Early Detection of Cancer

Age range

45 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oncology Unit, Puerta del Mar University Hospital

Cadiz, Andalusia, 11009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women living in the Bay Health District Cádiz-La Janda
  • Women aged between 45 and 69 years
  • Women invited to breast screening program and who attend it
  • Qualified women to give informed consent to participate in the study

Exclusion criteria

  • Women with a history of breast cancer

Treatment and study plan

Information

Other

The experimental information consists of receiving verbal and written evidence-based information about the benefits and risks of mammography screening program. The standard information consists of receiving the information that public institutions provide to the women invited to the screening program.

Primary outcomes

  1. Change from baseline in knowledge of women participating in the screening program

    Time frame: Before randomization (baseline) and one month later

    The primary outcome measure is the level of knowledge obtained in a specific questionnaire, in which there are 7 questions, of which 3 are quantitative with no assumptions and are scored with 2 points. There are also 4 qualitative questions that have 3 assumptions which are scored with 1 point. The maximum score is 10 and minimum 0. It is considered that a woman has made a choice based on adequate knowledge if she gets a score of 6 or more.

Secondary outcomes

  1. Attitudes, intention to participate, fear and anxiety of women participating in the screening program

    Time frame: Before randomization (baseline) and one month later. Two years later, women will be called to the follow-up mammography. At this time the real choice taken by woman will be investigated

    The investigators will investigate whether the attitudes of women towards mammography screening are positive or negative. They will respond to 4 questions that are scored from 0 to 6. To know their decision whether to participate in mammography screening they will answer "I am determined to participate" "I am determined not to participate" and "I am undecided". Effective participation will be investigated 2 years later. The level of anxiety and fear of cancer will be measured by "Hospital Anxiety and depression" scale.

Sponsors and collaborators

Lead sponsor

Andaluz Health Service

Other Gov

Registry information

Official study title

A Randomized Trial of an Evidence-informed Choice Based on Appreciation of Risks and Benefits for Women Participating in Mammography Screening

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 15, 2011
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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